Home NDC 59088-483 Lidotran
Product NDC 59088-483
11-digit product format 590880483
Labeler code 59088
Product ID 59088-483_cf715e54-c411-1e8f-e053-2995a90a076d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler PureTek Corporation
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2022-09-19
Substance LIDOCAINE HYDROCHLORIDE
Active strength 38.8 mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lidotran
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 38.8 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1723991 Internal RxNorm lookup 2611978 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59088-483-07 Lidotran 1 in 1 BAG CREAM 1 1 59088-483-07 Lidotran 85 g in 1 TUBE CREAM 85 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-483 LIDOTRAN (LIDOCAINE HYDROCHLORIDE) CREAM [PURETEK CORPORATION] 1 Current NDC, Legacy NDC, 2 package rows 20220920_cf715e54-c413-1e8f-e053-2995a90a076d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidotran LIDOCAINE HYDROCHLORIDE PureTek Corporation cf715e54-c413-1e8f-e053-2995a90a076d 2022-09-19 Warnings, Adverse reactions Exact identifier ndc (product): 59088-483
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59088-483-07 59088048307 1 TUBE in 1 BAG (59088-483-07) / 85 g in 1 TUBE 1 tube 2022-09-19 0000-00-00 No No Current